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NCT Number: NCT04440514

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.

Recruiting

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Key information

Conditions

Parastomal Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgical Wound Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Sykehuset Innlandet Hospital Trust, Brumunddal, Norway

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About this study

Endoscopic trans-abdominal preperitoneal plasty (TAPP) for parastomal hernia employing transversus abdominis release component separation (TAR) and reinforcement with mesh after the Sugarbaker principle, but placing mesh extraabdominally, anteriorly to the transversalis fascia. Laparoscopic and robotic procedures. Repair of concomitant midline hernia with endoscopic enhanced-view Rives-Stoppa technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parastomal hernia with need of repair

Exclusion criteria

  • < 18 years

Treatment and study plan

endoscopic preperitoneal repair of parastomal hernia

Procedure

repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement

Other names: ePauli

Primary outcomes

  1. Adverse events

    Time frame: 1 month

    Per- and post-operative complications

Secondary outcomes

  1. Late complications

    Time frame: 2 years

    Stoma function, pain, mesh complications

  2. Recurrence of hernia

    Time frame: 2 years

    Hernia recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

jan r lambrecht, PhD

CONTACT

[email protected]

99703962

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Registry information

Acronym: ePauli

Important dates

Study start
2020
Primary completion
2035
Study completion
2035
First posted
Jun 19, 2020
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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